| Primary Device ID | 00845533002103 |
| NIH Device Record Key | 5ebeb18e-5ba5-4855-8728-be321528e648 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Toxoplasma gondii IgG |
| Version Model Number | FA8001G |
| Catalog Number | FA8001G |
| Company DUNS | 080953946 |
| Company Name | ZEUS SCIENTIFIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845533002103 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-19 |
| Device Publish Date | 2025-11-11 |
| 00845533002073 - Fluorescent Treponemal Antibody- Absorbtion (FTA-ABS) | 2025-11-19 The Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies |
| 00845533002080 - Fluorescent Treponemal Antibody- Absorption Double Stain (FTA-ABS DS) | 2025-11-19 The Fluorescent Treponemal Antibody-Absorption Double Stain (FTA-ABS DS) Test System is designed to confirm positive non-trepone |
| 00845533002097 - Fluorescent Treponemal Antibody- Absorption (FTA-ABS) | 2025-11-19 The Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies |
| 00845533002103 - Toxoplasma gondii IgG | 2025-11-19The Toxoplasma gondii IgG is designed to detect the presence of circulating T. gondii antibodies in human sera and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. |
| 00845533002103 - Toxoplasma gondii IgG | 2025-11-19 The Toxoplasma gondii IgG is designed to detect the presence of circulating T. gondii antibodies in human sera and is for In Vit |
| 00845533002110 - Toxoplasma gondii IgM | 2025-11-19 The Toxoplasma gondii IgM is an indirect fluorescent antibody assay designed for the presumptive qualitative detection of IgM an |
| 00845533002004 - Sebia NTx Serum Test System | 2025-06-23 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen |
| 00845533001984 - Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) | 2025-06-19 The SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in |
| 00845533001991 - Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) | 2025-06-19 Standard IFA methods allow for the observation of several different patterns. Two patterns that have been well defined are C-AN |